Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02088593 |
Other study ID # |
Dawn |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2007 |
Est. completion date |
January 2010 |
Study information
Verified date |
May 2023 |
Source |
Medical University of South Carolina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Medical students score higher than the general population on measures of depression, anxiety,
fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might
contribute to these problems. From an internal validity standpoint, first year medical
students are an ideal group to study. The majority of the students will be matched on
variables such as education, age, and intelligence. However, more importantly, they have a
nearly identical life style when it comes to factors such as schedule, living conditions,
level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students
randomized to sleep hygiene counseling plus simulated dawn will report less depression,
anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized
questionnaires) than students randomized to just sleep hygiene counseling.
Description:
There is a substantial and growing body of literature that has identified medical students as
a group that suffers from increased levels of depression, anxiety, and other markers of
"psychological distress". Other studies have demonstrated that in conjunction with the
"psychological distress", medical students suffer from sleep deprivation, sleep disruption,
and daytime sleepiness. Finally there is some preliminary evidence that residents and interns
show increased symptoms of fatigue. It might reasonably be assumed that all of these symptoms
are inter-related and more importantly detrimental to both the student and those patients
under their care. There have been interventional studies aimed at educating participants on
stress management, however these attempts have had only limited success.
Circadian rhythms are biological rhythms that contribute to most of our bodies' physiological
processes. It has been determined that light is the major environmental cue that influences
the setting of our circadian rhythm. Under ideal circumstances exposure to natural sunlight
is sufficient to maintain a consistent and synchronized circadian rhythm. Often times this is
not the case. Reduced exposure to natural light and increased exposure to artificial light
are just two influencing factors.
Artificial light therapy has been successfully applied to the treatment of disorders of
circadian rhythms as well as the treatment of some affective disorders. Most notably, light
therapy has been shown to be effective in treating symptoms of depression and sleep
disruption, specifically in patients with seasonal affective disorder, non-seasonal major
depression, delayed sleep phase syndrome, advanced sleep phase syndrome, and sub-syndromal
levels of each of these.
The theoretical mechanism of action is reviewed by Terman et al and asserts that morning
bright light therapy advances and stabilizes the circadian rhythm of individuals who have
delayed or drifting rhythms. There is subsequent synchronization and entrainment of the
individual's endogenous rhythm with the environmental rhythm of daily life as reviewed in.
The timing, duration, and type of light delivered are of paramount concern, as improper
delivery of therapy has been shown to have no advantage over placebo. One method of light
delivery is simulated dawn light therapy. Simulated dawn light therapy works by gradually
increasing light exposure over a specified period of time at the end of the sleep period.
This gradually increasing light exposure during the sleep period is in contrast to
traditional light therapy, which is delivered at full intensity after wake time. Simulated
dawn has shown great promise as being just as effective as traditional light therapy but with
the additional advantages of being more time efficient, easier to use, and more easily
tolerated. All of these factors are important considerations in the application of this
intervention to medical students, as being short on time and under significant stress are
both hallmarks of medical education. The following proposal is a novel approach, using light
therapy, to improve the mental well-being of first year medical students.